Human placental tissue has been used in various surgical procedures, including skin transplantation and ocular surface disorders, for over a century. The tissue has been shown to provide good wound protection, prevent surgical adhesions, reduce pain, reduce wound dehydration, and provide anti-inflammatory and anti-microbial effects.
The placenta is a fetomaternal organ consisting of a placental globe, umbilical cord, associated membranes (chorionic membrane and amniotic membrane), other gelatins, fluids, cells and extracellular material. The chorionic membrane and the amniotic membrane are attached by loose connective tissue and make up the placental sac. The innermost membrane of the placental sac is the amniotic membrane, which comes into contact with the amniotic fluid that surrounds the fetus. The amniotic membrane is avascular and lined by simple columnar epithelium overlying a basal membrane. The chorionic membrane is the outermost layer of the sac and is heavily cellularized. The placental membranes have an abundant source of collagen that provides an extracellular matrix to act as a natural scaffold for cellular attachment in the body. Collagen provides a structural tissue matrix that facilitates, among other things, cell migration and proliferation in vivo.
Various manufacturing processes have also been employed to create wound coverings composed of amniotic membrane, chorionic membrane, or intact amniotic and chorionic membranes recovered aseptically from human birth tissue after elective Cesarean surgery. There remains a need, however, for membranes that are uniquely processed and combined with components of the amniotic fluid to enhance the tissue's physical properties and to provide a material that can aid in the repair of bone and soft tissue.
Catheters are tube-like devices which are inserted into a portion of a person's body in order to transport liquids, gases, and sometimes semisolids, into or out of that portion of the body. For instance, urinary catheters are used to transport urine collected in the bladder out of the body via the urinary tract. Other types of catheters, such as gastronomy devices, transport fluids into and out of various segments of the gastrointestinal system, primarily the stomach.
In order to provide a means of retaining the catheter within the body, inflatable bag catheters were introduced many years ago. Foley (U.S. Pat. No. 3,409,016) taught an elongated catheter having a secondary lumen for inflating a retention balloon at a distal end of the catheter once the distal end is positioned within the body. Such catheters are now generally referred to as “Foley” catheters out of respect for the contribution made by Dr. Foley. Improvements on Foley catheters continue to find their way into the market place today. Thus, there remains a need for an improvement upon a Foley catheter whereby a dual balloon system allows for the sterile recovery of fluid while sealing off a pressurized biological membrane(s) to prevent fluid leakage and membrane tear and/or rupture.